Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

ATROPINE SULFATE (NDA-206289)

(ATROPINE SULFATE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

Download Data

Expand all

09/18/2025 (SUPPL-14)

Approved Drug Label (PDF)

4 Contraindications

4.1 Hypersensitivity
Additions and/or revisions underlined:

Atropine Sulfate Ophthalmic Solution 1% is contraindicated in patients who have demonstrated a previous hypersensitivity or known allergic reaction to any ingredient of the formulation.

5 Warnings and Precautions

5.3 Risk of Contamination

Newly added subsection:

Do not touch the dropper tip to the eye, eyelids, or any other surface as this may contaminate the solution.

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion:

Risk Summary

There are no adequate and well-controlled studies of atropine sulfate administration in pregnant women to inform a drug-associated risk. Adequate animal development and reproduction studies have not been conducted with atropine sulfate. In humans, 1% atropine sulfate is systemically bioavailable following topical ocular administration [see Clinical Pharmacology (12.3)].

Atropine Sulfate Ophthalmic Solution 1% should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

8.2 Lactation

PLLR conversion:

Risk Summary0

There is no information to inform risk regarding the presence of atropine in human milk following ocular administration of atropine sulfate to the mother. The effects on breastfed infants and the effects on milk production are also unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for atropine sulfate and any potential adverse effects on the breastfed child from atropine sulfate.

8.4 Pediatric Use
Additions and/or revisions underlined:

The safety and effectiveness of Atropine Sulfate Ophthalmic Solution 1% have been established in pediatric patients aged 3 months and older. Use of Atropine Sulfate Ophthalmic Solution 1% is supported by evidence from adequate and well-controlled trials with additional safety data from published literature.

Due to the potential for systemic absorption, the use of Atropine Sulfate Ophthalmic Solution 1% in pediatric patients aged 3 months to 3 years should be limited to no more than one drop per eye per day.

Use in pediatric patients younger than 3 months of age is not recommended.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Risk of Contamination

Advise patients to not touch the dropper tip to the eye, eyelids, or any other surface as this may contaminate the solution. Keep the bottle tightly closed.

Instillation Site Pain

Advise patients that drops will sting upon instillation

Sensitivity to Light and Blurred Vision

Advise patients that they will experience sensitivity to light and blurred vision which may last for a couple of weeks.